EaRly impAct theraPy With Ceftazidime-avibactam Via rapID Diagnostics Versus Standard of Care Antibiotics and Diagnostics in Patients With Bloodstream Infection, Hospital-acquired Pneumonia or Ventilator-associated Pneumonia Due to Pseudomonas Aeruginosa or Carbapenemase Producing Enterobacterales (RAPID)

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

The goal of this clinical trial is to propose a seamless intervention linking rapid bacterial isolate identification and antibiotic resistance gene detection and targeted antibiotic prescription to minimise time between infection onset and appropriate treatment in patients with Pseudomonas aeruginosa or carbapenemase producing Enterobacterales infections. This is an investigator initiated trial. The primary hypothesis is that these interventions will lead to improved clinical outcomes amongst patients with hospital-acquired bloodstream infection, hospital-acquired pneumonia or ventilator-associated pneumonia due to carbapenem non-susceptible Pseudomonas aeruginosa or Enterobacterales, compared to standard antibiotic susceptibility testing. Patients will be randomised to either a control or intervention arm. Patients randomised to the intervention arm will have relevant specimens analysed by rapid microbiological diagnostics and will have early availability of ceftazidime-avibactam if appropriate. Patients randomised to the control arm, will have samples analysed by clinical microbiology laboratories using standard of care diagnostics. Antibiotics will be available to these patients as per usual institutional practice.

Eligibility
Participation Requirements
Sex: All
Healthy Volunteers: f
View:

• patient developed clinical symptoms compatible with bloodstream infection, hospital-acquired or ventilator-associated pneumonia (hospital-acquired and ventilator-associated pneumonia should fulfil US CDC NHSN criteria) AND,

• an appropriate specimen has been received by the participating laboratory - that is, a blood culture bottle showing Gram negative bacilli or a respiratory sample collected for clinical purposes showing Gram negative bacilli on Gram stain;

Locations
Other Locations
Malaysia
University Malaya Medical Centre
NOT_YET_RECRUITING
Kuala Lumpur
Taiwan
Kaohsiung Medical University Hospital
NOT_YET_RECRUITING
Kaohsiung City
Taichung Veterans General Hospital
RECRUITING
Taichung
Thailand
Sunpasitthiprasong Hospital
NOT_YET_RECRUITING
Ubon Ratchathani
Contact Information
Primary
Kithalakshmi Vignesvaran
kitha@nus.edu.sg
90300178
Time Frame
Start Date: 2023-12-12
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 1900
Treatments
Active_comparator: Intervention
Samples from patients randomised to the intervention arm will undergo the BioFire FilmArray systems. Patients will be then administered with the study drug, ceftazidime-avibactam when Pseudomonas aeruginosa or carbapenemase producing Enterobacterales detected.
No_intervention: Control
Patients randomised to the control arm, will have samples analysed by clinical microbiology laboratories using standard of care diagnostics. Antibiotics treatment will be administered as per usual institutional practice from hospital supplies.
Related Therapeutic Areas
Sponsors
Leads: National University of Singapore
Collaborators: Pfizer, Biomerieux inc

This content was sourced from clinicaltrials.gov